High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects

June 30, 2021 updated by: Manar Elbaz, Horus University

Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects

The purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.

Study Overview

Detailed Description

Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.

Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.

So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.

So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Damietta, Egypt, 34518
        • Outpatient clinic - Faculty of Physical Therapy - Horus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects have to meet all the following criteria in order to participate in the study:

    1. Overweight subjects with age from 25 to 35 years.
    2. Body mass index will be range from 25 to 29.9 kg/m2.
    3. Waist circumference ≥ 80 cm2.
    4. A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.

Exclusion Criteria:

  • Subjects with the following disorders will be excluded from participating in this study:

    1. Musculoskeletal, cardiovascular disorders.
    2. Asthma, chronic obstructive pulmonary diseases.
    3. Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
    4. History of stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High intensity interval training
Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.
  1. Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).
  2. Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
  3. Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit.
Active Comparator: Intermittent fasting
Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.
Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the change in Vo2max
Time Frame: Baseline and 2 months post-intervention
Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
Baseline and 2 months post-intervention
Assessing the change in body weight
Time Frame: Baseline and 2 months post-intervention
Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
Baseline and 2 months post-intervention
Assessing the change in waist hip circumference
Time Frame: Baseline and 2 months post-intervention
Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
Baseline and 2 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Manar Elbaz, Demonstrator, Horus University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Manar_MSc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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